Tag Archives: REMS

FDA Releases Guidance on REMS Modifications and Revisions

On July 9, 2019, the U.S. Food and Drug Administration (FDA) released a final guidance on changes to approved Risk Evaluation and Mitigation Strategies (REMS). For certain drugs, the FDA may require a REMS as an additional risk management plan to ensure that the benefits of the drug outweigh the risks. The final guidance describes the three different types of changes to an approved REMS, how application holders should submit changes to REMS, and how the FDA will process submissions from application holders for changes to REMS.

View the full Alert on the Duane Morris LLP website.

FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) recently published a report titled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS),” which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA’s Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization.